Kornimate/medical-research-clean huggingface dataset:
effects of covid-19 lockdown in exercising early postmenopausal women

Conditions: Exercise; Detraining; Muscle Weakness; Muscle Atrophy

Summary: while "conditioning" by exercise training has been widely evaluated, the available literature on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies with or with almost complete mechanical and/or metabolic immobilization/sedation of the respective functional system (e.g. paralysis, bedriddenness). vice versa, the effects of moderately long interruptions of dedicated types of exercise while maintaining everyday activity are rarely addressed. however, this topic is of high relevance, e.g. considering that breaks of health-related exercise programs due to increased family/occupational stress, vacation or temporary orthopedic limitation are rather frequent in everyday life. in the present project we aimed to determine the effects of 3 months of physical deconditioning due to covid-19 induced lockdown after 13 month of high intensity endurance and resistance exercise in early postmenopausal women on parameters related to health and physical fitness.


Eligibility criteria:
inclusion criteria: * (early)postmenopausal women, ( normal menopause, 1-5 years post) * osteopenia and osteoporosis (bone mineral density \<-1.0 sd t-score) exclusion criteria: * bmd \<-4.0 sd t-score * prevalent clinical, low-trauma fractures * diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids \>7.5 mg/d or bisphosphonate therapy); individual case assessment * diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment * severe cardiovascular events (e.g. stroke, coronary infarction) in the past. * other conditions, diseases that exclude exercise training or testing
breast milk and infant growth among lean, overweight and diabetic mothers

Conditions: Obesity; Type 2 Diabetes; Gestational Diabetes

Summary: childhood obesity is a critical global public health concern. breastfeeding is the ideal choice for infant nutrition. however, rapid and excess weight gain during infancy predicts later, even among breastfed infants. this risk is higher if mothers are obese and/or diabetic. composition of bioactive components of breast milk may differ based between mothers who are normal weight (nw), overweight, or who have diabetes. obesity and type 2 diabetes are associated with overall increases in inflammation and oxidative stress, but how breast milk composition is affected remains unknown. the investigators overarching goal is to determine how maternal obesity and type 2 diabetes impacts human breast milk composition and how differences in composition may impact infant growth and fat development. the investigators are undertaking a study that follows 20 normal weight, 20 obese, 20 gestational diabetic, and 20 type 2 diabetic mothers and their infants over the first 4 months of life. the investigators will track infant weight and fat gain and monitor maternal glucose control. the investigators will also collect breast milk samples over the first 4 months and measure concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and nutrient composition in milk. the investigators predict that concentrations of growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and markers of oxidative stress will be lowest in breast milk from nw mothers, higher in breast milk from obese and gestational diabetic mothers, and highest in type 2 diabetic mothers' breast milk. the investigators expect these differences will be most pronounced in the first 2 weeks after birth. the investigators also predict that breast milk concentrations of these biomarkers will be associated with infant fat gain. what the investigators find will help understand how early infant nutrition and growth may affect that child's later risk of obesity.


Eligibility criteria:
inclusion criteria: * between 28-40 weeks gestation * plan to exclusively breastfeed for at least 5 months * between 20 - 35 years old * carrying a singleton pregnancy * parity less than or equal to 5 * pre-pregnancy bmi between 18.5 and 39.9 exclusion criteria: * no known infant anomalies or birth defects * maternal type 1 diabetes * maternal major medical condition (ie: kidney disease or pre-eclampsia) * delivery of the infant before 35 weeks gestation * smoking during pregnancy

Keywords: human milk infant growth obesity diabetes breastfeeding
the abc study: assessment of breast density classification

Conditions: Breast Cancer

Summary: the maria® breast imaging system is a ce-marked radiofrequency (rf) medical imaging device. the system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. it is the intention that maria® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. this study will collect the data required for the classifier to be developed.


Eligibility criteria:
inclusion criteria: * to be eligible to participate in this study, a subject must meet all the following criteria: * attending a symptomatic or assessment breast clinic at the study site * female sex * 18 years or older * able to provide informed consent * not in any identified, vulnerable group exclusion criteria: * a potential subject who meets any of the following criteria will be excluded from participation in this study: * unable to mount maria® patient bed * unable to lie in the prone position for a period of up to 15 minutes * patients who have undergone biopsy less than 5 days before the maria® scan * patients with implanted electronics * patients with breast implants * patients with nipple piercings (unless they are removed prior to the maria® scan) * breast sizes too small or too large to be suitable for the array participants recruited the same day are not subject to any additional screening criteria other than that described above. however, participants being recruited and consenting to the use of previously- taken mammography will need to provide information on key points in order to assess the eligibility of their mammograms for use. this will include information on: * whether they have initiated or discontinued use of a hormonal contraceptive since their last mammogram * whether they have initiated or discontinued use of hormone replacement therapy since their last mammogram * whether they believe that they have had a change in menopausal status since their last mammogram participants who answer yes to any of the above will not be eligible for participation.
obesity and oral contraceptive failure

Conditions: Contraception; Fetal Growth Retardation; Infant, Small for Gestational Age; Obesity

Summary: contraceptive failure is the primary cause of unintended pregnancy in the united states. with obesity rates at epidemic proportions, any association between obesity and strategies that prevent undesired pregnancies constitutes a significant public health and economic concern. evidence from recent epidemiological studies and our preliminary data (sub-therapeutic levels of steroid hormones due to drug clearance and half-life) suggest that obesity reduces oral contraceptive efficacy. furthermore, preliminary analysis suggested that a sub-group of obese women, defined by their own birth weight, are at higher risk of contraceptive failure. further studies are necessary to investigate whether birth weight, a surrogate marker of in utero growth restriction, is a useful diagnostic marker for the identification of women prone to contraceptive failure. such an understanding is critical to finding a contraceptive strategy with better efficacy for these women. the overall goal of this project is to test pharmacokinetics of oral contraceptive agents in obese women with low birth weight and compare to obese women with normal birth weight. the main hypothesis for this proposal is that an adverse in utero environment programs the expression and function of enzymes and transporters that underlie pharmacokinetics of oral contraceptives, and leads to contraceptive failure. reproductive-aged, ovulatory women of obese bmi \>30 kg/m2 with normal birth weight (5.5-8 lbs; n=10) and low birth weight (\<5.5 lbs; n=10), will be placed on oral contraceptives for 1 month. at several key time points, synthetic steroid pharmacokinetics, gonadotropins (luteinizing hormone, follicle-stimulating hormone) and ovarian hormone levels (estradiol, progesterone) will be monitored.


Eligibility criteria:
inclusion criteria: * age 18 to 35. * single progesterone level of 3 ng/ml or greater during the luteal phase (days 18 to 25) in the menstrual cycle prior to dosing with oral contraceptives. exclusion criteria: * absolute/relative contraindications to ethinyl estradiol and levonorgestrel. * impaired liver function. * history of deep venous thrombosis. * hypertension (\> 140/90). * diabetes with vascular changes. * migraines with aura or neurological changes. * history of myocardial infarction, pulmonary embolus, stroke or breast cancer. * anemia (hematocrit \< 36%). * actively seeking or involved in a weight loss program (must be weight stable) * pregnancy, breastfeeding, or seeking pregnancy. * diagnosis of polycystic ovarian syndrome. * recent (4 week) use of hormonal contraceptives (patch or ring included), intrauterine, or implantable hormonal contraception. * depoprovera use within six months. * current use of drugs that interfere with metabolism of sex steroids. * smokers. * uncontrolled thyroid dysfunction.

Keywords: pharmacokinetics pharmacology, clinical drug efficacy drug failure contraceptive agents
safety and efficacy of levomilnacipran er in adolescent participants with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran er relative to placebo in adolescent outpatients (12-17 years) with major depressive disorder (mdd). in addition, the study is designed to obtain pharmacokinetics (pk) data to guide dose selection for future pediatric studies of levomilnacipran.

study lvm-md-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. the study will be approximately 10 weeks in duration: * 1-week screening/washout period * 8-week double-blind treatment period * 1-week double-blind down-taper period participants who meet the eligibility criteria at visit 2 (baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.

Eligibility criteria:
key inclusion criteria: * male or female outpatients;12-17 years of age * meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for mdd, confirmed by kiddie schedule for affective disorders and schizophrenia for school-age children--present and lifetime (k-sads-pl) * score ≥ 40 on the children's depression rating scale-revised (cdrs-r) at visits 1 and 2 * clinical global impressions-severity (cgi-s) score ≥ 4 at visits 1 and 2 * reliable caregiver * physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ecg) normal or not clinically significant key psychiatric exclusion criteria: * dsm-iv-tr-based diagnosis of an axis i disorder other than mdd that is the primary focus of treatment * mental retardation or amnestic or other cognitive disorders * significant suicide risk: * suicide attempt within the past year or * investigator judgment (based on psychiatric interview and columbia-suicide severity rating scale (c-ssrs)) key treatment-related exclusion criteria: * allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (ssri) or serotonin-norepinephrine reuptake inhibitors (snri) * use of prohibited concomitant medication that cannot be discontinued other key medical exclusion criteria: * any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety * liver enzyme tests aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 2x the upper limit of normal (uln) * clinically significant cardiovascular disorders * seizure disorder or risk of seizure * drug or alcohol abuse or dependence (within the past year) * positive urine drug screen or blood alcohol
open versus robotic retromuscular repair in medium to large ventral hernias

Conditions: Ventral Hernia; Incisional Hernia; Abdominal Wall Defect

Summary: this study investigates on the effect of two different operative techniques to treat large abdominal wall defects. the goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (rvhr) leads to a better outcome than the open ventral hernia repair (ovhr). the main questions it aims to answer are: length of stay after the operation rate of complications rate of recurrence and reoperations quality of life. participants will: either be operated using the rvhr or ovhr will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.


Eligibility criteria:
inclusion criteria: * patient age \>18 years * informed consent obtained * transverse diameter of ventral hernia \>4cm - 15cm * eligible to open and minimally-invasive surgery according to preoperative anaesthetic assessment exclusion criteria: * precedent hernia treatment with mesh placement in the retromuscular space * precedent anterior or posterior component separation or transversus abdominis release (tar) * active wound infection * current cancer diagnosis * presence of ileostomy, colostomy or ileal conduit * liver disease defined by the presence of ascites * end-stage renal disease requiring dialysis * need of an emergency surgery * pregnancy criteria for participating surgeons each participating surgeon has performed 20 or more ovhr and rvhr.
integral study: a longitudinal study of surgeries and lasers in glaucoma

Conditions: Glaucoma

Summary: the aim of this study is to create a large-scale register of all glaucoma patients diagnosed, followed and treated in a large tertiary centre specialising in glaucoma, in order to analyse whether specific factors influence the progression of the disease or guide our choice of treatment. this should lead to a better understanding of the disease and the factors to be taken into account when choosing the best treatment option for each patient, leading to safer, more effective and patient-centred care.

glaucoma encompasses a group of chronic diseases characterized by progressive retinal nerve fibre loss and a concomitant pattern of visual field damage, eventually leading to blindness. to date, it is still considered the first cause of irreversible blindness worldwide. in recent years, treatment options for glaucoma have soared, and ophthalmologists can resort to a wide selection of drops, laser procedures and surgical techniques to reduce intraocular pressure, and slow the progression of the disease. the choice of the technique, however, often depends on personal preferences and it is still unclear if a specific technique is more efficient or safe, or if any patient-depending factors should guide the choice of treatment. the aim of this study is to create a large-scale register of all glaucomatous patients diagnosed, followed-up and treated in a large glaucoma-specialised tertiary centre, to analyse if any specific factor influence the progression of the disease or guide our treatment choice. this should lead to a better understanding of the disease itself and of the factors that should be considered when choosing the best treatment option for each patient, leading to safer, more efficient and more patient-centered care. this registry is thus of great importance for both patients and clinicians in the diagnosis and treatment of glaucoma. the study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective and prospective.

Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (iop \> 24 mmhg, medicated or not) * patients who received treatment (medical, laser or surgical) at the glaucoma centre, montchoisi clinic and swiss visio montchoisi * age: 18 years old or older * able and willing to provide informed written or verbal consent exclusion criteria: * patients who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
hypophosphatemia in the intensive care: a one-day point prevalence survey

Conditions: Critically Ill

Summary: the point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value \< 0.8 mmol/l) in international critical care settings

the survey will be conducted on one single day in each centre (d-day), within a week defined by the project coordinator (international pi). on d-day, the local investigators will be asked 1. to complete questions aiming at describing their icu (number of beds, number of patients present on d-day, type medical/surgical/other, local phosphate reference value, presence of an hypophosphatemia treatment protocol in the icu and route of phosphate delivery in case of hypophosphatemia) 2. to indicate how many patients had a blood phosphate \<0.08 mmol/l, for each patient with hypophosphatemia, to record the exact lowest value on d-day, and to record age, number of days in icu on d-day, presence (or not) of artificial nutrition and continuous renal replacement therapy, if any phosphate administration is ongoing data will be recorded in and electronic case report form (e-crf) in redcap, and analysed with descriptive statistics no outcome data will be recorded (pure point-prevalence) there is no intervention

Eligibility criteria:
inclusion criteria: blood phosphate value \< 0.8 mmol - exclusion criteria: blood phosphate value \>0.8 mmol/l -

Keywords: phosphate
efficacy evaluation of a commercial preparation containing lactobacillus casei dg on the reduction of the painful symptoms related to the irritable bowel syndrome (ibs). a pilot clinical study

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the efficacy of a treatment with lactobacillus casei dg in the reduction of the painful symptoms in patients affected by irritable bowel syndrome. after that, the secondary object is to evaluate if the reduction of painful symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.


Eligibility criteria:
inclusion criteria: * out-patients with diagnosis of irritable bowel syndrome (ibs) according to rome iii diagnostic criteria for functional gastrointestinal disorders * previous colonoscopy (within 24 month prior the enrollment) with negative results * written informed consent exclusion criteria: * systemic or topical therapy with steroids and glucocorticoids such as beclomethasone dipropionate or budesonide, ongoing or within a month prior the enrollment * therapy with antibiotics or probiotics, ongoing or within a month prior the enrollment * inflammatory bowel diseases * copro-paraxitological examination with positive results * bowel disease with infectious, actinic, endocrine or drug-related origin * immunodeficiency * diagnosis of malignant cancer within 5 years prior the enrollment * renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disorders, if found to be clinically relevant * any severe disease that may interfere with the treatment; * abuse of alcohol, drugs or medication, psychotropic drugs * diagnosis of dementia or other disorders that can cause a progressive deterioration of capacity of discernment or mental and physical disability which reduces the ability to follow the prescribed therapy; * previous participation in this study * pregnant or nursing (lactating) women

Keywords: lactobacillus casei dg irritable bowel syndrome
patient-reported outcomes in the bergen early cardiac rehabilitation study

Conditions: Coronary Artery Disease

Summary: an intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.

the main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.

Eligibility criteria:
inclusion criteria: * diagnosis of coronary artery disease * \>=18 years of age * has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training. exclusion criteria: * cognitive impairment * unstable angina pectoris * aortic stenosis * left ventricular ejection fraction \<30% * heart failure nyha class iii-iv * serious arrhythmia in need of treatment * being on the waiting list for percutaneous coronary intervention or coronary artery bypass grafting.

Keywords: cardiac rehabilitation adherence patient-reported outcomes post-traumatic growth anxiety depression adherence lifestyle self-reported health
efficacy, safety, pharmacokinetics of icp-488 in patients with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis Patients

Summary: this is a multicenter, randomized, double-blind, placebo-controlled phase iii clinical study to evaluate the efficacy, safety, pk characteristics of icp-488 in chinese adults with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: eligible subjects must meet all of the following criteria: 1. subjects voluntarily participate in this study and have signed informed consent. 2. male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the icf. 3. history of plaque psoriasis ≥6 months at baseline. 4. subjects need to receive systemic therapy and/or phototherapy. 5. the following three criteria were met: a) psoriasis area and severity index (pasi) score ≥12; b) psoriasis affected body surface area (bsa) ≥10%; c) static physician overall assessment (spga) ≥3 scores exclusion criteria: 1. the diagnosis was non-plaque psoriasis. 2. subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments. 3. presence of infection or immune-related disease. 4. subjects with a history of tb or at risk for tb. 5. received related treatment within the time window specified in the protocol. 6. an interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong cyp1a2/cyp3a4 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong cyp1a2/cyp3a4 inhibitory or inductive effect during study participation. 7. the investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol. 8. pregnant or lactating women, or women who plan to become pregnant during study participation. 9. a history of severe drug allergies. 10. any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.